Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problem
No Information (3190)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical products: 00585004202, distal femoral component, lot # 63767709, unknown segmental stem extension.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2019 - 04156.
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Event Description
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It was reported that in an unknown timeframe, the patient was revised due to instability.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint sample was evaluated and the reported event was not confirmed.Visual examination of the returned devices exhibited signs of being implanted, however, there was no obvious damaged identified that would indicate instability.Review of the device history record could not be performed as the part and lot number of the device were not identified.A definitive root cause was unable to be determined.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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No further event information available at the time of this report.
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Search Alerts/Recalls
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